Canada & Other Global Markets Regulatory Services

Our Experience in Other Global Markets Regulatory

MCRA's expert regulatory, quality, and clinical consultants provide the knowledge and experience to support medical device companies looking to gain access to established and emerging markets. In addition to the regulatory service offering described, MCRA can assist with quality management system and manufacturing compliance (e.g., ISO 13485), MDSAP preparation and implementation, internal audits, supplier/vendor audits, and clinical investigation services including pre-study activities and study execution.

MCRA assists companies with all aspects of their global regulatory needs, from full-service assistance to more refined scopes, based on the needs of the company. MCRA partners with your internal team to provide insight and/or added bandwidth to meet internal and external timelines. MCRA's regulatory team provides clients with a customized service offering, assisting with a specific component of their project or leading and implementing strategies from initial concept development through market launch. Get in touch with us today to learn more.

MCRA's other global markets regulatory services include:
 

• Providing a detailed regulatory pathway for your product in each market including, but not limited to, device classification, non-clinical and clinical data expectations, PMS and vigilance responsibilities, labeling requirements including country specific language requirements, and applicable fees from the Health Authorities.

• Developing and completing your registration documentation. 

• Evaluate and assess current non-clinical data and clinical evidence to identify potential gaps and the path forward to meet regulatory requirements per market.

• Identifying and providing strategic guidance where prior market authorizations from markets such as the US and EU, can be leveraged for abridged reviews.

Integrated Global Market Roadmap

• Identify applicable requirements and regulatory bodies.

• Design comprehensive strategic plans and timelines for the introduction of devices to global markets throughout the product lifecycle.

• Identify and provide strategic guidance where prior market authorizations from markets such as the US and EU can be leveraged for abridged reviews.

• Generate a single STED and/or IMDRF Table of Contents (ToC) submission documentation package, per device type, that can be leveraged across multiple global markets requiring only country-specific updates.

• Critically assess and prepare market access and data generation strategies early in the process to establish clinical and non-clinical needs.

Product Registration

• Develop, create, and compile your product registration documents using MCRA's in-house expertise to ensure your products get to market as efficiently as possible.

• Determine the regulatory pathway and execute successful registrations in Canada, Australia, New Zealand, and several markets in Asia-Pacific (APAC), Middle East and Africa (MEA), and Latin America.

• Evaluate and asses current data sets for gaps and provide recommendations to address gaps to meet each market's requirements.

• Provide response services to address Regulatory Authority questions (e.g., Health Canada, TGA)

Clinical Evidence / Post-Market Surveillance

• Develop and/or update clinical evaluation reports (CER) which are compliant with internationally recognized standards such as MEDDEV 2.7/1 Rev. 4 and IMDRF MDCE WG/N56FINAL:2019.

• Evaluate your clinical evidence for data sufficiency to demonstrate conformity with the relevant Essential Principles or other key regulatory benchmarks.

• Build a comprehensive and methodical literature search process that can be utilized across markets reducing the need for multiple and cumbersome literature reviews.

• Develop and/or update post-market surveillance reports which are compliant with other global market requirements.

• Navigate vigilance requirements per other global markets to determine compliant reportability and timelines.

Canada Regulatory Services

Whether you are interested in learning about the regulatory process and requirements in Canada or if you are ready to sell your device in Canada, MCRA's regulatory team brings 10+ years of experience with the Canadian regulatory process. MCRA's in-house expertise has successfully obtained Medical Device Licenses (MDL) for Class II, Class III, and Class IV devices across multiple therapeutic technologies.

For unlicensed devices where you are interested in running a clinical investigation with sites in Canada, MCRA's regulatory and clinical teams have the expertise and experience to develop and submit the Investigational Testing Authorization (ITA) application to Health Canada, as well as provide responses to any questions from Health Canada.

With MCRA's in-house expertise, our services include:
 

• Providing a detailed regulatory pathway for your product in Canada including, but not limited to, device classification, non-clinical and clinical data expectations, PMS and vigilance responsibilities, labeling requirements, and applicable fees from Health Canada.

• Developing and completing your Canadian MDL or Medical Device Establishment License (MDEL) application. MCRA can also act as your regulatory correspondent with Health Canada for your MDL.

• Creating and submitting an ITA application.

• Evaluate and assess current non-clinical data and clinical evidence to identify potential gaps and the path forward to meet Health Canada requirements.

• Implementing or modifying your ISO 13485 quality management system to meet MDSAP and Canadian requirements.